- Merck & Co. (North Wales, PA)
- …operational responsibilities for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary supplies planning/tracking, ... expertise with team members.May interact with internal and external stakeholders (eg, study team, vendors, committees) in support of clinical trial… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …NNI and competitor products Demonstrates thorough knowledge of all promoted NNI approved clinical studies and the skill to engage customers (prescribers, support ... current co-promotion partners. Internally, the VSR reports to the Virtual Sales Business Manager . The VSR also interacts and collaborates on a regular basis with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic...and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …metrics, and provide this feedback through regularly scheduled 1:1 meetingsCollaborate with Clinical Study Manager on SA deliverablesParticipates in ... who assist in planning and in the execution of clinical studies in adherence to the protocol,...International Conference on Harmonization (ICH) guidelines.The Manager , Study Associates will ensure the SAs provide clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical ... as a project manager for other activities involving assigned product(s) or clinical studies , as needed Qualifications: Successful candidates will be able to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to applicable Daiichi Sankyo and regulatory requirements. Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management ... and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/ studies...Plan, Clinical Study Reports).Leads and drives the data review process in… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …qualityMust have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sitesPositive management style, ... on dermatology, ophthalmology and onco-dermatology. Description: Sun is seeking a Sr. Manager , Clinical Outsourcing within its Clinical Outsourcing Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... regulatory agency sponsor inspection with the goal to ensure GCO/ clinical teams are prepared and trained and study...GCO/ clinical teams are prepared and trained and study documentation is quality controlled and available, and all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium ... and immune disorders. Summary Position leads statistical support for medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …contracts. Performs financial reconciliation and negotiation of Vendor contracts prior to study termination and contract closure. Manages all aspects of sourcing and ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility ... packages.Proactively reaches out and build relationship with key program and study staff at clinical development and operational team levels to drive adoption of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies , Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for ... submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low ... immune disorders.Summary Position leads statistical support for low to medium complexity studies including contributing to development of optimal study design,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …CROs (eg Site identification, Feasibility, Site selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory ... contract review. Act as primary point of contact from clinical operations for assigned trials.Oversee study start...predefined timelines.Prepare and implement Quality control plan in assigned studies and ensure that clinical studies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities ... both technical and career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.Responsibilities:Protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify...and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan Ministry of Health, Labor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...encore abstracts, reviews, and supplements) in collaboration with Publications Manager Independent Medical Education (IME) Assist in developing medical… more
